Federal Register Vol. 80, No.72,

Background

On October 10, 2014, the Department published its Preliminary Results of the antidumping duty administrative review of OTR tires from the PRC and invited interested parties to comment on the preliminary results. We granted parties an extension of time to submit case and rebuttal briefs.2 On December 11, 2014, we received case briefs from Petitioners,3 GTC, and Double Coin. On December 19, 2014, we received a rebuttal brief from Trelleborg. On December 23, 2014, we received rebuttal briefs from Petitioners, GTC, Double Coin, and Zhongce. On December 30, 2014, the Department extended the deadline for the final results until April 8, 2015.4 In accordance with timely requests from parties, on February 25, 2015, the Department held a public hearing.5 We conducted this administrative review in accordance with section 751 of the Tariff Act of 1930, as amended (the “Act”).

The merchandise covered by this order includes new pneumatic tires designed for off-the-road and off-highway use, subject to certain exceptions. The subject merchandise is currently classifiable under Harmonized Tariff Schedule of the United States (“HTSUS”) subheadings: 4011.20.10.25, 4011.20.10.35, 4011.20.50.30, 4011.20.50.50, 4011.61.00.00, 4011.62.00.00, 4011.63.00.00, 4011.69.00.00, 4011.92.00.00, 4011.93.40.00, 4011.93.80.00, 4011.94.40.00, and 4011.94.80.00. The HTSUS subheadings are provided for convenience and customs purposes only; the written product description of the scope of the order is dispositive.6

All issues raised in the case and rebuttal briefs filed by parties in this review are addressed in the Issues and Decision Memorandum, which is hereby adopted by this notice. A list of the issues that parties raised and to which we responded in the Issues and Decision Memorandum follows as an appendix to this notice. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (“ACCESS”).7 ACCESS is available to registered users at http://access.trade.gov and it is available to all parties in the Central Records Unit, Room 7046 of the main Department of Commerce building. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly on the Internet at http://www.trade.gov/enforcement/. The signed Issues and Decision Memorandum and electronic version of the Issues and Decision Memorandum are identical in content.

As noted in the Preliminary Results, we received a no-shipment certification from Trelleborg.8 Consistent with its practice, the Department asked U.S. Customs and Border Protection (“CBP”) to conduct a query on potential shipments made by Trelleborg during the POR; CBP did not provide any evidence that contradicts Trelleborg's claim of no shipments.9 Based on Trelleborg's certification, our analysis of CBP information, and analysis of interested parties' comments, we determine that Trelleborg did not have any reviewable transactions during the POR.10

We continue to find that Double Coin Group Jiangsu Tyre Co., Ltd., Double Coin Group Shanghai Donghai Tyre Co., Ltd., and Double Coin Holdings, Ltd. are affiliated pursuant to section 771(33)(E) of the Act and should be collapsed together and treated as a single company (collectively, “Double Coin”), pursuant to the criteria laid out in 19 CFR 351.401(f).11

In the Preliminary Results, we determined that GTC, Zhongce, and Zhongwei are eligible for separate-rate status; we also determined that Double Coin was part of the PRC-wide Entity.12 We made no changes to these determinations for the final results.13

Normally, the Department's practice is to look for guidance from section 735(c)(5)(A) of the Act, to assign to separate rate companies that were not individually examined a rate equal to the average of the rates calculated for the individually examined respondents, excluding any rates that are zero, de minimis, or based entirely on adverse facts available.14 In this case, we found one mandatory respondent, Double Coin, to be part of the PRC-wide entity. The other mandatory respondent, GTC, is receiving a separate rate calculated from its own sales and production data. To determine a rate for the unselected separate rate companies, we find it appropriate to use the margin calculated for GTC, which was also found to be separate from the PRC-wide entity with respect to its export activities, and which rate is not zero or de minimis nor based entirely on facts available. Therefore, we are assigning GTC's calculated margin as the rate assigned to non-examined entities which demonstrated their eligibility for a separate rate.

Double Coin, one of the companies that the Department selected as a mandatory respondent in this administrative review, failed to demonstrate absence of de facto government control over export activities due to the fact that its controlling shareholder is wholly-owned by the State-owned Assets Supervision and Administration Commission of the State Council and the significant level of control this majority shareholder wields over the respondent's Board of Directors.15 As a result, we determine that Double Coin is part of the PRC-wide entity.

Because Double Coin provided the Department with its verified sales and production data, we are able to calculate a margin for an unspecified portion of a single PRC-wide entity, but cannot do so for the remaining unspecified portion of the entity. As the Department must calculate a single margin for the PRC-wide government controlled entity and there is insufficient information on the record with respect to the composition of the PRC-wide entity, as facts available pursuant to section 776(a)(1) of the Act, we calculated a simple average of the previously assigned PRC-wide rate (210.48 percent) 16 and Double Coin's calculated margin (0.14 percent) as the rate applicable to the PRC-wide entity. Accordingly, the Department revised the PRC-wide entity rate to 105.31 percent for these final results.17

Based on an analysis of the comments received, we made certain calculation programming changes and revisions to the valuation of certain factors of production. For further details on the changes we made for these final results, see the Issues and Decision Memorandum. See also Memorandum to the File titled “Final Results of the 2012-2013 Administrative Review of the Antidumping Duty Order on Certain New Pneumatic off-The-Road Tires from the People's Republic of China: Surrogate Value Memorandum,” dated April 8, 2015; Memorandum to the File titled “2012-2013 Administrative Review of the Antidumping Duty Order on Certain New Pneumatic Off-the-Road Tires from the People's Republic of China: Analysis of the Final Results Margin Calculation for Guizhou Tyre Co., Ltd.,” dated April 8, 2015; and Double Coin Final Analysis Memorandum.

As a result of this administrative review, we determine that the following weighted-average dumping margins exist for the period September 1, 2012, through August 31, 2013:

The Department shall determine, and CBP shall assess, antidumping duties on all appropriate entries covered by this review pursuant to section 751(a)(2)(C) of the Act and 19 CFR 351.212(b).19 The Department intends to issue assessment instructions to CBP 15 days after the date of publication of these final results of review.

For customers or importers of GTC for which we do not have entered value, we calculated importer- (or customer-) specific antidumping duty assessment amounts based on the ratio of the total amount of dumping duties calculated for the examined sales of subject merchandise to the total sales quantity of those same sales.20 For customers or importers of GTC for which we received entered-value information, we have calculated importer- (or customer-) specific antidumping duty assessment rates based on importer- (or customer-) specific ad valorem rates.21 For the non-examined separate rate companies, we will instruct CBP to liquidate all appropriate entries at 11.34 percent. For the PRC-wide entity, including Double Coin, we will instruct CBP to liquidate all appropriate entries at 105.31 percent.

The Department recently announced a refinement to its assessment practice in non-market economy (“NME”) cases.22 Pursuant to this refinement in practice, for entries that were not reported in the U.S. sales databases submitted by companies individually examined during this review, the Department will instruct CBP to liquidate such entries at the NME-wide rate. In addition, if the Department determines that an exporter under review had no shipments of subject merchandise, any suspended entries that entered under that exporter's case number (i.e., at that exporter's rate) will be liquidated at the NME-wide rate.

The following cash deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) For the exporters listed above, the cash deposit rate will be equal to the weighted-average dumping margin identified in the “Final Results” section; (2) for previously investigated or reviewed PRC and non-PRC exporters that are not under review in this segment of the proceeding but that received a separate rate in a previous segment, the cash deposit rate will continue to be the exporter-specific rate (or exporter-producer chain rate) published for the most recently completed segment of this proceeding; (3) for all PRC exporters of subject merchandise which have not been found to be entitled to a separate rate, the cash deposit rate will be the PRC-wide rate of 105.24 percent; and (4) for all non-PRC exporters of subject merchandise which have not received their own rate, the cash deposit rate will be the rate applicable to the PRC exporter(s) that supplied that non-PRC exporter. The cash deposit requirements, when imposed, shall remain in effect until further notice.

This notice serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping and/or countervailing duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of the antidumping and/or countervailing duties occurred and the subsequent assessment of double antidumping duties.

This notice also serves as a reminder to parties subject to administrative protective order (“APO”) of their responsibility concerning the return or destruction of proprietary information disclosed under the APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.

We will disclose the calculations performed within five days of the date of publication of this notice to parties in this proceeding, in accordance with 19 CFR 351.224(b).

We are issuing and publishing the final results and notice in accordance with sections 751(a)(1) and 777(i)(1) of the Act.

CNCS is particularly interested in comments that:

• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of CNCS, including whether the information will have practical utility;

• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

• Enhance the quality, utility, and clarity of the information to be collected; and

• Minimize the burden of the collection of information on those who are expected to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology (e.g., permitting electronic submissions of responses).

The information collection is requested of AmeriCorps Members who are applying for the benefit (or in some cases, member of their households); information collected is used to determine a member's eligibility based upon statutory, regulatory, and program eligibility requirements. In addition, the information collection is requested of the child care providers to determine a child care provider's eligibility to provide the child care service.

Information is collected via hardcopy and electronically through an online application system.

CNCS seeks to renew the current AmeriCorps Child Care Application and add four new instruments: The AmeriCorps Member Application, Attendance Sheet, Member Update Form, and Statement of Work Activities.

The information collection will otherwise be used in the same manner as the existing application. The current application is due to expire on 7/31/2015.

Type of Review: Renewal.

Agency: Corporation for National and Community Service.

Title: AmeriCorps Child Care Program Forms.

OMB Number: 3045-0142.

Agency Number: None.

Affected Public: AmeriCorps Members and Child Care Providers.

Total Respondents: 1,400 total: 700 AmeriCorps Members and 700 Child Care Providers.

Frequency: Annual.

AmeriCorps Member Application: 60 minutes.

Member Update Form: 5 minutes.

Statement of Work Activities Form (completed by Member): 10 minutes.

AmeriCorps Child Care Provider Application: 40 minutes.

Attendance Sheet (completed by Provider and signed by Member): 20 minutes.

Estimated Total Burden Hours: 1,575 hours.

Total Burden Cost (capital/startup): None.

Total Burden Cost (operating/maintenance): None.

Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget approval of the information collection request; they will also become a matter of public record.

The committee meeting is being held under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150.

Purpose of the Meeting: The Board is chartered to provide independent advice and recommendations to the Secretary of the Army on construction and rehabilitation project investments on the commercial navigation features of the inland waterways system of the United States. At this meeting, the Board will receive briefings and presentations regarding the investments, projects and status of the inland waterways system of the United States and conduct discussions and deliberations on those matters. The Board is interested in written and verbal comments from the public relevant to these purposes.

Proposed Agenda: At this meeting the agenda will include the status of funding for inland navigation projects and studies, the status of the Inland Waterways Trust Fund, the status and path forward for the Olmsted Locks and Dam Project, the Locks and Dams 2, 3, and 4 Monongahela River Project; status of Chickamauga Lock Project; status of Inner Harbor Navigation Canal (IHNC) Lock General Re-evaluation Report; an update on the Inland Marine Transportation System (IMTS) Investment Program (Capital Investment Strategy); Lock Performance Monitoring System (LPMS) Data and Reporting Process; and a summary of the Board's advice and recommendations submitted to the Congress regarding the Fiscal Year 2016 President's Budget.

Availability of Materials for the Meeting. A copy of the agenda or any updates to the agenda for the May 14, 2015 meeting will be available at the meeting. The final version will be provided at the meeting. All materials will be posted to the Web site after the meeting.

Public Accessibility to the Meeting: Pursuant to 5 U.S.C. 552b, as amended, and 41 CFR 102-3.140 through 102-3.165, and subject to the availability of space, this meeting is open to the public. Registration of members of the public who wish to attend the meeting will begin at 8:15 a.m. on the day of the meeting. Seating is limited and is on a first-to-arrive basis. Attendees will be asked to provide their name, title, affiliation, and contact information to include email address and daytime telephone number at registration. Any interested person may attend the meeting, file written comments or statements with the committee, or make verbal comments from the floor during the public meeting, at the times, and in the manner, permitted by the committee, as set forth below.

Special Accommodations: The meeting venue is fully handicap accessible, with wheelchair access. Individuals requiring special accommodations to access the public meeting or seeking additional information about public access procedures, should contact Mr. Pointon, the committee DFO, or Mr. Lichtman, the ADFO, at the email addresses or telephone numbers listed in the FOR FURTHER INFORMATION CONTACT section, at least five (5) business days prior to the meeting so that appropriate arrangements can be made.

Written Comments or Statements: Pursuant to 41 CFR 102-3.105(j) and 102-3.140 and section 10(a)(3) of the Federal Advisory Committee Act, the public or interested organizations may submit written comments or statements to the Board about its mission and/or the topics to be addressed in this public meeting. Written comments or statements should be submitted to Mr. Pointon, the committee DFO, or Mr. Lichtman, the committee ADFO, via electronic mail, the preferred mode of submission, at the addresses listed in the FOR FURTHER INFORMATION CONTACT section in the following formats: Adobe Acrobat or Microsoft Word. The comment or statement must include the author's name, title, affiliation, address, and daytime telephone number. Written comments or statements being submitted in response to the agenda set forth in this notice must be received by the committee DFO or ADFO at least five (5) business days prior to the meeting so that they may be made available to the Board for its consideration prior to the meeting. Written comments or statements received after this date may not be provided to the Board until its next meeting. Please note that because the Board operates under the provisions of the Federal Advisory Committee Act, as amended, all written comments will be treated as public documents and will be made available for public inspection.

Verbal Comments: Members of the public will be permitted to make verbal comments during the Board meeting only at the time and in the manner allowed herein. If a member of the public is interested in making a verbal comment at the open meeting, that individual must submit a request, with a brief statement of the subject matter to be addressed by the comment, at least three (3) business days in advance to the committee DFO or ADFO, via electronic mail, the preferred mode of submission, at the addresses listed in the FOR FURTHER INFORMATION CONTACT section. The committee DFO and ADFO will log each request to make a comment, in the order received, and determine whether the subject matter of each comment is relevant to the Board's mission and/or the topics to be addressed in this public meeting. A 15-minute period near the end of meeting will be available for verbal public comments. Members of the public who have requested to make a verbal comment and whose comments have been deemed relevant under the process described above, will be allotted no more than three (3) minutes during this period, and will be invited to speak in the order in which their requests were received by the DFO and ADFO.

If the Corps determines that preparation of a DMMP is necessary, an accompanying Environmental Assessment in accordance will be prepared in accordance with the National Environmental Policy Act (NEPA). The primary federal actions under consideration are dredging, dredged material placement/disposal, and transport of dredged material for the purpose of aquatic disposal and/or upland beneficial reuse. The City of Petaluma is the non-federal sponsor (NFS). An Environmental Assessment is intended to be sufficient in scope to address the federal, state and local requirements and environmental issues concerning the proposed activities and permit approvals.

Project Site and Background Information: The Petaluma River federal navigation project is located on the Northern California coast about 35 miles to the north of San Francisco. It consists of two portions: The Upper Channel that begins in Petaluma City and extends 14 miles to the mouth of Petaluma River at San Pablo Bay (near the Highway 37 Bridge); and the Across the Flats (ATF) portion that continues southeast of the Highway 37 Bridge and extends 5 miles into the deeper water of San Pablo Bay. It is a shallow draft navigation project that supports light commercial and sport fishing, and recreational boating.

Both the channel width and depth vary throughout the entire length of the federal project. An 8 foot depth is authorized for the five miles of the ATF portion extending into San Pablo Bay (200 foot wide channel) and as far upstream as Western Avenue in the City of Petaluma (100 foot wide channel). This includes a 300 foot by 400 foot turning basin. The channel then reduces to 50 feet wide with a 4 foot depth until the Washington Street Bridge and from there it reduces to a 40 foot width and a 4 foot depth for an additional 935 linear feet.

Historically, dredged sediment from the Upper Channel was placed at an upland disposal site located downstream of the turning basin. The dredged sediment from the ATF portion has historically been placed at the San Pablo in-bay disposal site SF-10.

Proposed Action(s): The San Francisco District, US Army Corps of Engineers, is evaluating whether there is sufficient placement/disposal capacity and verifying economic justification to support continued federal and non-federal maintenance dredging over the next 20 years.

Issues: Potentially significant issues associated with the project may include: air quality emissions, biological resource impacts, hazards and hazardous materials, hydrology and water quality, noise, traffic and transportation, and cumulative impacts from past, present and reasonably foreseeable future projects.

Scoping Process: The U.S. Army Corps of Engineers is seeking participation and input of all interested federal, state, and local agencies, Native American groups, and other concerned private organizations or individuals through this public notice. The purpose of the public meeting is to solicit comments regarding the potential impacts and environmental issues associated with the proposed action to be considered. A meeting will be held on April 30, 2015, at 7:00 p.m. (PDT). The draft PA is expected to be available for public review and comment in late summer of 2015.

The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

Title of Collection: National Household Education Survey 2016 (NHES:2016) Full-scale Data Collection.

OMB Control Number: 1850-0768.

Type of Review: A reinstatement of a previously approved information collection.

Respondents/Affected Public: Individuals.

Total Estimated Number of Annual Responses: 187,536.

Total Estimated Number of Annual Burden Hours: 30,373.

Abstract: The National Household Education Surveys Program (NHES) is conducted by the National Center for Education Statistics' (NCES). NHES is NCES's principal mechanism for addressing education topics appropriate for households rather than establishments. Such topics cover a wide range of issues, including early childhood care and education, children's readiness for school, parent perceptions of school safety and discipline, before- and after-school activities of school-age children, participation in adult education and training, parent involvement in education, school choice, homeschooling, and civic involvement. The NHES consists of a series of rotating surveys using a two-stage design in which a household screener collects household membership and key characteristics for sampling and then appropriate topical survey(s) are mailed to sample members. Data from the NHES are used to provide national cross-sectional estimates on populations of special interest to education researchers and policymakers. NHES surveys were conducted approximately every other year from 1991 through 2007 using random digit dial (RDD) methodology; beginning in 2012 NHES began collecting data by mail to improve response rates. This submission seeks clearance to conduct NHES:2016, which will repeat the child topical surveys conducted in 2012: the Parent and Family Involvement in Education (PFI) and the Early Childhood Program Participation (ECPP), and will include the first adult topical survey in NHES since 2005, the Adult Training and Education Survey (ATES). The adult survey was developed in conjunction with the Interagency Working Group on Expanded Measures of Enrollment and Attainment (GEMEnA) and was pilot tested in the 2014 NHES Feasibility Study.

Notice of this meeting is required under Section 10(a)(1)(2) of the Federal Advisory Committee Act (FACA).

The teleconference will be closed to the public because it is concerned with recommending applicants for a vacancy. Discussions will require full and frank advice from Governing Board members. This advice will involve professional judgments on the relative merits and qualifications of the proposed candidate and respective work experience. Such personnel matters involve the discussion of information that is of a personal nature, the disclosure of which would be a clearly unwarranted invasion of personal privacy and, therefore, is protected from disclosure by exemptions 2 and 6 of § 552b(c) of Title 5 of the United States Code.

Minutes of the closed teleconference will be certified by the Board Chairman and retained in the public record.

In the Federal Register of March 30, 2015 (80 FR 16648), on page 16648, in the middle of the third column under the heading Overview Information, and on page 16656, in the middle of the first column, under 3. Submission Dates and Times, we change the deadline date for transmittal of pre-applications from “April 29, 2015,” to “May 5, 2015.”

This information collection request contains: (1) OMB No:. “New”; (2) Information Collection Request Title: Partnership for Energy Sector Climate Resilience; (3) Type of Request: New collection; (4) Purpose: To enhance the resilience of the nation's power sector to extreme weather and climate change, the Department of Energy is establishing a partnership program with power sector companies. On an annual basis, participating companies are asked to report on activities they have undertaken to improve their resilience to extreme weather and climate change. This information will help facilitate improved resilience throughout the sector and better inform the Department's activities in support of these efforts. (5) Annual Estimated Number of Respondents: 25; (6) Annual Estimated Number of Total Responses: 50 (first year, 25 thereafter). (7) Annual Estimated Number of Burden Hours: 212 hours; (8) Annual Estimated Reporting and Recordkeeping Cost Burden: $8,959 total program-wide annual costs.

Statutory Authority: Title XIII of the Energy Independence and Security Act of 2007 calls for a variety of activities to support the modernization of the Nation's electricity transmission and distribution system to maintain a reliable and secure electricity infrastructure. In addition, Executive Orders, 13514 (Federal Leadership in Environmental, Energy and Economic Performance) and 13653 (Preparing the United States for the Impacts of Climate Change) also set forth a number of activities that would be supported by the information collected under this request.

Type of Request: Three-year extension of the FERC-552 information collection requirements with no changes to the current reporting requirements.

OMB Control No.: 1902-0242.

Abstract: The Commission uses the information collected within the FERC-552 to provide greater transparency concerning the use of indices to price natural gas and how well index prices reflect market forces. The collection also includes transactions that contribute to, or may contribute to natural gas price indices. Many market participants rely on indices as a way to reference market prices without taking on the risks of active trading.

FERC-552 had its genesis in the Energy Policy Act of 2005 1 , which added section 23 of the Natural Gas Act (NGA). Section 23 of the NGA, among other things, directs the Commission “to facilitate price transparency in markets for the sale or transportation of physical natural gas in interstate commerce, having due regard for the public interest, the integrity of those markets, and the protection of consumers.” 2

Type of Respondents: Wholesale natural gas market participants

Estimate of Annual Burden: 3 The Commission estimates the total Public Reporting Burden for this information collection as:

The total estimated annual cost burden to respondents is $478,652 [6,660 hours ÷ 2,080 4 hours/year = 3.201923 * $149,489/year 5 = $478,652].

The estimated annual cost of filing the FERC-552 per response is $719 [$478,652 ÷ 666 responses = $719/response]

Comments: Comments are invited on: (1) Whether the collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden and cost of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information collection; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology.

I. General Information A. Does this action apply to me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

EPA has received applications to register pesticide products containing active ingredients not included in any currently registered pesticide products. Pursuant to the provisions of FIFRA section 3(c)(4) (7 U.S.C. 136a(c)(4)), EPA is hereby providing notice of receipt and opportunity to comment on these applications. Notice of receipt of these applications does not imply a decision by the Agency on these applications.

1. EPA Registration Numbers: 100-811; 100-1317. Docket ID number: EPA-HQ-OPP-2015-0180. Applicant: Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27409. Active ingredient: Cyprodinil. Product type: Fungicide. Proposed use: Nut, tree, group 14-12, except almond, except pistachio. Contact: RD.

2. EPA Registration Numbers: 100-791; 100-799. Docket ID Number: EPA-HQ-OPP-2015-0014. Applicant: Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27409. Active ingredient: Mefenoxam. Product type: Fungicide. Proposed use: Rapeseed crop subgroup 20A. Contact: RD.

3. EPA Registration Numbers: 4787-55; 4787-61; 67760-75. Docket ID Number: EPA-HQ-OPP-2015-0179. Applicant: Cheminova A/S, c/o Cheminova, Inc., 1600 Wilson Blvd., Suite 700, Arlington, VA 22209-2510. Active ingredient: Flutriafol. Product type: Fungicide. Proposed use: Hops, dried cones. Contact: RD.

4. EPA Registration Numbers: 10163-6414 and 10163-6415. Docket ID Number: EPA-HQ-OPP-2014-0922. Applicant: Gowan Company, P.O. Box 5569, Yuma, AZ 85366. Active ingredient: Zoxamide. Product type: Fungicide. Proposed use: Ginseng, Tomato Subgroup 8-10A, Small Fruit Vine Climbing except fuzzy kiwifruit Subgroup 13-07F, and Tuberous and Corm Subgroup 1C. Contact: RD.

5. EPA Registration Numbers: 66222-35 and 11678-57. Docket ID Number: EPA-HQ-OPP-2014-0232. Applicant: Makhteshim-Agan of North America, Inc., 3120 Highwoods Blvd., Suite 100, Raleigh, NC 27604. Active ingredient: Novaluron. Product type: Insecticide. Proposed use: Avocado; Carrot; Succulent Bean; Vegetable, Fruiting, Crop Group 8-10; Fruit, Pome, Crop Group 11-10; Cherry Subgroup 12-12A; Peach Subgroup 12-12B; and Plum Subgroup 12-12C. Revisions to the Label to Include Uses on Greenhouse-Grown Cucumber. Contact: RD.

All principal campaign committees of candidates who participate in the Illinois Special Primary and Special General Elections shall file a 12-day Pre-Primary Report on May 27, 2015; a 12-day Pre-General Report on July 12, 2015; and a Post-General Report on August 23, 2015. (See charts below for the closing date for each report.)

All principal campaign committees of candidates participating only in the Special Primary Election shall file a 12-day Pre-Primary Report on May 27, 2015. (See charts below for the closing date for each report.)

Political committees filing on a semi-annual basis in 2015 are subject to special election reporting if they make previously undisclosed contributions or expenditures in connection with the Illinois Special Primary or Special General Elections by the close of books for the applicable report(s). (See charts below for the closing date for each report.)

Committees filing monthly that make contributions or expenditures in connection with the Illinois Special Primary or Special General Elections will continue to file according to the monthly reporting schedule.

Additional disclosure information in connection with the Illinois Special Elections may be found on the FEC Web site at http://www.fec.gov/info/report_dates.shtml.

Principal campaign committees, party committees and Leadership PACs that are otherwise required to file reports in connection with the special elections must simultaneously file FEC Form 3L if they receive two or more bundled contributions from lobbyists/registrants or lobbyist/registrant PACs that aggregate in excess of $17,600 during the special election reporting periods. (See charts below for closing date of each period.) 11 CFR 104.22(a)(5)(v), (b).

Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency request or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, ACL/AoA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, ACL/AoA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of ACL/AoA's functions, including whether the information will have practical utility; (2) the accuracy of ACL/AoA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques when appropriate, and other forms of information technology. ACL/AoA estimates the burden of this collection of information as follows: Annual submission of the Program Performance Reports are due 90 days after the end of the budget period and final project period.

Respondents: Federally Recognized Tribes, Tribal and Native Hawaiian Organizations receiving grants under Title VI, Part A, Grants for Native Americans; Title VI, Part B, Native Hawaiian Program and Title VI, Part C, Native American Caregiver Support Program.

Estimated Number of Responses: 266.

Total Estimated Burden Hours: 731.5.

The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

FDA has approved for marketing the human drug product AUBAGIO (teriflunomide). AUBAGIO is indicated for treatment of patients with relapsing forms of multiple sclerosis. Subsequent to this approval, the USPTO received a patent term restoration application for AUBAGIO (U.S. Patent No. 5,679,709) from sanofi-aventis Deutschland GMBH, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated January 31, 2014, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of AUBAGIO represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

FDA has determined that the applicable regulatory review period for AUBAGIO is 2,940 days. Of this time, 2,542 days occurred during the testing phase of the regulatory review period, while 398 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became effective: August 27, 2004. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on August 27, 2004.

2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: August 12, 2011. FDA has verified the applicant's claim that the new drug application (NDA) for AUBAGIO (NDA 202992) was submitted on August 12, 2011.

3. The date the application was approved: September 12, 2012. FDA has verified the applicant's claim that NDA 202992 was approved on September 12, 2012.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 5 years of patent term extension.

Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments and ask for a redetermination by June 15, 2015. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by October 13, 2015. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) electronic or written comments and written or electronic petitions. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. If you submit a written petition, two copies are required. A petition submitted electronically must be submitted to http://www.regulations.gov, Docket No. FDA-2013-S-0610.

Comments and petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

FDA has approved for marketing the human drug product AUBAGIO (teriflunomide). AUBAGIO is indicated for treatment of patients with relapsing forms of multiple sclerosis. Subsequent to this approval, the USPTO received a patent term restoration application for AUBAGIO (U.S. Patent No. 6,794,410) from Aventis Pharmaceuticals Inc., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated January 31, 2014, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of AUBAGIO represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

FDA has determined that the applicable regulatory review period for AUBAGIO is 2,940 days. Of this time, 2,542 days occurred during the testing phase of the regulatory review period, while 398 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became effective: August 27, 2004. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on August 27, 2004.

2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: August 12, 2011. FDA has verified the applicant's claim that the new drug application (NDA) for AUBAGIO (NDA 202992) was submitted on August 12, 2011.

3. The date the application was approved: September 12, 2012. FDA has verified the applicant's claim that NDA 202992 was approved on September 12, 2012.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,625 days of patent term extension.

Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments and ask for a redetermination by June 15, 2015. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by October 13, 2015. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) electronic or written comments and written or electronic petitions. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. If you submit a written petition, two copies are required. A petition submitted electronically must be submitted to http://www.regulations.gov, Docket No. FDA-2013-S-0610. Comments and petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

The Center for Veterinary Medicine (CVM) issued guidance for industry (GFI) #171 entitled “Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles” to describe the procedures that the Agency recommends for the review of requests for waiver of in vivo demonstration of bioequivalence for generic soluble powder oral dosage form products and Type A medicated articles.

The Generic Animal Drug and Patent Term Registration Act (GADPTRA) of 1988 (Pub. L. 100-670) permitted generic animal drug manufacturers to copy those pioneer animal drug products that were no longer subject to patent or other marketing exclusivity protection. The approval for marketing these generic products is based, in part, upon a demonstration of bioequivalence between the generic product and pioneer product. This guidance clarifies circumstances under which FDA believes the demonstration of bioequivalence required by the statute does not need to be established on the basis of in vivo studies for soluble powder oral dosage form products and Type A medicated articles. The data submitted in support of the waiver request are necessary to validate the waiver decision. The requirement to establish bioequivalence through in vivo studies (blood level bioequivalence or clinical endpoint bioequivalence) may be waived for soluble powder oral dosage form products or Type A medicated articles in either of two alternative ways. A biowaiver may be granted if it can be shown that the generic soluble powder oral dosage form product or Type A medicated article contains the same active and inactive ingredient(s) and is produced using the same manufacturing processes as the approved comparator product or article. Alternatively, a biowaiver may be granted without direct comparison to the pioneer product's formulation and manufacturing process if it can be shown that the active pharmaceutical ingredient(s) (API) is the same as the pioneer product, is soluble, and that there are no ingredients in the formulation likely to cause adverse pharmacologic effects. For the purpose of evaluating soluble powder oral dosage form products and Type A medicated articles, solubility can be demonstrated in one of two ways: “USP definition” approach or “Dosage adjusted” approach. The respondents for this collection of information are pharmaceutical companies manufacturing animal drugs. FDA estimates the burden for this collection of information as follows in Tables 1 and 2 of this document. The source of the above data is records of generic drug applications over the past 10 years.

In the Federal Register of January 12, 2015 (80 FR 1506), FDA published a 60-day notice requesting public comment on the proposed collection of information. One comment was received, however it did not respond to any of the four information collection topics solicited and is therefore not addressed by the Agency.

FDA estimates the burden of this collection of information as follows:

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Some foreign countries require manufacturers of FDA-regulated products to provide an export certificate for the products they wish to export to that country. A Certificate of Free Sale is a certificate (not pertaining to a particular production lot or export consignment) that indicates that the particular product is marketed in the United States or eligible for export, and that the particular manufacturer has no unresolved enforcement actions pending before or taken by FDA. FDA's Center for Food Safety and Applied Nutrition (CFSAN) issues such certificates for food, food additives, seafood, dietary supplements, and cosmetics. Interested persons may request a certificate by using the electronic CFSAN Certificate Application Process, which is part of FDA Unified Registration and Listing System, or by submitting a paper Form FDA 3613d for cosmetic products or a paper Form FDA 3613e for food products. We use the information submitted to determine whether to issue the requested certificate.

OMB has approved the submission of requests for export certificates on paper Forms FDA 3613d and FDA 3613e and, electronically, via the CFSAN Certificate Application Process under OMB control number 0910-0498. This notice announces that, to ensure the efficient review of the information collection by OMB under the PRA, we are seeking to obtain a new OMB Control Number for Forms FDA 3613d and FDA 3613e and the CFSAN Certificate Application Process to reflect that the electronic submission system for food and cosmetic export certificates is separate from the electronic submission system associated with export certificates for other FDA-regulated products approved under OMB control number 0910-0498. Upon OMB approval of this information collection request, we will adjust the burden hours associated with Forms FDA 3613d and FDA 3613e and the CFSAN Certificate Application Process approved under OMB control number 0910-0498.

We request the following information on Form FDA 3613d and the CFSAN Certificate Application Process, as currently approved by OMB: The name of and contact information for the requester; the name of and contact information for the exporting company (if different from requester); a designation of the type of certificate requested (“general” or “product-specific”); if product-specific, a list of the exact brand names of the products; the contact person, company name and address where the requested certificate should be sent; and, the name and account number (if applicable) of the requester's preferred carrier for delivery of the certificate. Finally, Form FDA 3613d and the CFSAN Certificate Application Process requires the requester's signature, the name and title of the person signing the form, as well as the date signed.

We request the following information on Form FDA 3613e and the CFSAN Certificate Application Process, as currently approved by OMB: The name of and contact information for the manufacturer, as well as the manufacturer's state license or registration number; the name of and contact information for the exporting company (if different from manufacturer), as well as the exporting company's state license or registration number; a description of the shipment including the product, the common name, the manufacturer, and a description or additional comments; the name of the country to which the requester of the certificate intends to ship the product; the contact person, firm name and address where the requested certificate should be sent; and, the name and account number (if applicable) of the requester's preferred carrier for delivery of the certificate. Form FDA 3613e and the CFSAN Certificate Application Process requires the requestor to submit an original or copy of the applicable product label or labels. Finally, Form FDA 3613e and the CFSAN Certificate Application Process requires the submitter's signature, the name and title of the person signing the form, as well as the date signed.

Description of Respondents: The respondents to this collection of information are firms interested in exporting U.S.-manufactured food and cosmetic products to foreign countries that require export certificates.

In the Federal Register of January 9, 2015 (80 FR 1422), FDA published a 60-day notice requesting public comment on the proposed collection of information. We received four comments in response to the notice. The comments generally supported the necessity and practical utility of the information collected during the export certificate application process for food, however no comments were received regarding the export certificate application process for cosmetics. Our responses to the comments are discussed below.

One comment had concerns about our request for the manufacturer's (and exporter's, if different from manufacturer) state license or registration number on Form FDA 3613e, stating that doing so could allow third parties unnecessary and/or unauthorized access to confidential commercial information. We appreciate this comment and note that we do not place the firm's state license or registration numbers on the certificates we issue. In addition, confidential commercial information is protected from disclosure under the Freedom of Information Act under sections 552(a) and (b) (5 U.S.C. 552(a) and (b)), and under our regulations at 21 CFR part 20. At the same time, the state license or registration number is necessary for our review of the application. We verify the license or registration and investigate inspection data on the listed products.

One comment suggested ways we might modify the electronic submission system, including expanding the number of characters that may be entered per data field; developing corporate identification numbers and passwords, permitting a product label to be submitted electronically through the CFSAN Certificate Application Process; and, permitting a submitter to pay the application fees electronically within the CFSAN Certificate Application Process. Similarly, another comment discussed possible changes to the content of the Export Certificates or the Certificates of Free Sale that we issue for food, including incorporating pagination to indicate the number of sequential pages that would be part of the certificate; adding statements that the product is fit for human consumption, may be freely sold or exported in the United States, and, is produced in a manner consistent with good manufacturing practice; and providing the applicant the ability to request the type of certificate referenced on the header of the document and to request additional services, such as a notarized certificate document or expedited processing. While we are not able to accommodate the suggested modifications at this time, we will consider them as we contemplate future revisions to the relevant forms and solicit additional comments at that time through a notice published in the Federal Register.

Finally, one comment was received that did not respond to any of the four information collection topics solicited and is therefore not addressed by the Agency.

FDA estimates the burden of this collection of information as follows:

For the purpose of this information collection request, we are basing our estimate of the average burden per response in column 6 of table 1 on the estimates previously submitted to and approved by OMB under control number 0910-0498. Our estimate of the average burden per response in column 6 of table 1 varies according to the product category for which the certificate is requested. We base our estimates of the total annual responses in column 5 of table 1 on our experience with certificate applications received in the past 2 fiscal years. Some respondents send in requests as often as three or four times a month while others may submit only periodic requests.

We expect that most if not all firms requesting export certificates in the next 3 years will choose to take advantage of the option of electronic submission via the CFSAN Certificate Application Process. Thus, our burden estimates in table 1 are based on the expectation of 100 percent participation in the electronic submission process. The opportunity to provide the information in electronic format could reduce the Agency's previous estimates for the time to prepare each submission. However, as a conservative approach for the purpose of this analysis, we are assuming that the opportunity to submit the information in electronic format will have no effect on the average time to prepare a submission.

Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comment on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Under the prescription drug user fee provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (sections 735 and 736 (21 U.S.C. 379g and 379h)), as amended, FDA has the authority to assess and collect user fees for certain drug and biologics license applications (BLAs) and supplements to those applications. Under this authority, pharmaceutical companies pay a fee for certain new human drug applications (NDAs), BLAs, or supplements submitted to the Agency for review. Because the submission of user fees concurrently with applications and supplements is required, review of an application by FDA cannot begin until the fee is submitted. The Prescription Drug User Fee Cover Sheet, Form FDA 3397, is designed to provide the minimum necessary information to determine whether a fee is required for review of an application, to determine the amount of the fee required, and to account for and track user fees. The form provides a cross-reference of the fee submitted for an application by using a unique number tracking system. The information collected is used by FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) to initiate the administrative screening of NDAs, BLAs, and/or, supplemental applications to those applications.

Respondents to this collection of information are new drug and biologics manufacturers. Based on FDA's database system for fiscal year (FY) 2014, there are an estimated 290 manufacturers of products subject to the Prescription Drug User Fee Act (Pub. L. 105-115). The total number of annual responses is based on the number of submissions received by FDA in FY 2014. CDER received 3,005 annual responses that include the following submissions: 128 NDAs; 7 BLAs; 1,586 manufacturing supplements; 1,081 labeling supplements; and 203 efficacy supplements. CBER received 705 annual responses that include the following submissions: 11 BLAs; 611 manufacturing supplements; 64 labeling supplements; and 19 efficacy supplements. The estimated hours per response are based on past FDA experience with the various submissions.

FDA estimates the burden of this collection of information as follows:

Transporters serve an important role in the ADME of drugs, and in turn could affect their safety or efficacy. The AAPS/ITC joint transporter workshop in 2015 aims to continue on the success of preceding AAPS workshops on Drug Transporters meetings (2003, 2005, 2007, 2009, 2011, 2013) and ITC transporter workshops (2008 and 2012) to provide an opportunity for scientists in academia, industry, and regulatory agencies to exchange ideas about the cutting-edge science. Key areas of focus will include the following:

• Transporter tools of the future (e.g., organs-on-a-chip, humanized mouse models, and transporter imaging);

• Interplay of drug metabolism and transporters;

• “State of the art” sessions on:

○ Emerging transporters,

○ Endogenous biomarkers to assess transporter-mediated drug efficacy and toxicity or to predict drug-drug interactions, and

○ Quantitative transporter proteomics in translational drug metabolism and pharmacokinetics;

• “Hot Topics” in the translation of transporter data to the clinic;

• Prospective transporter substrate modeling; and

• Review of comments related to transporters following recent guidances issued from the regulatory agencies, including FDA, European Medicines Agency, and Pharmaceuticals and Medical Devices Agency (Japan).

• To provide a forum for open interchange, dissemination, and discussion of cutting edge science in transporters among scientists from academia, industry, and regulatory agencies.

• To develop a mutual understanding on what needs to be done in transporter research and how to translate knowledge obtained from the bench to bedside.

• To facilitate and enhance translational applications of new development in transporter research in drug development and regulatory review of new therapeutics.

The Agency intends to add a nonvoting industry representative to the following advisory committees:

A. Advisory Committee for Pharmaceutical Science and Clinical Pharmacology: Reviews and evaluates scientific, clinical, and technical issues related to the safety and effectiveness of drug products for use in the treatment of a broad spectrum of human diseases.

B. Anesthetic and Analgesic Drug Products Advisory Committee (formerly Anesthetic and Life Support Drugs Advisory Committee): Reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in anesthesiology and surgery.

C. Anti-Infective Drugs Advisory Committee: Reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of infectious diseases and disorders.

D. Antiviral Drugs Advisory Committee: Reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of acquired immune deficiency syndrome (AIDS), HIV-related illnesses, and other viral, fungal, and mycobacterial infections. (Terminated February 15, 2015).

E. Arthritis Advisory Committee: Reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of arthritis, rheumatism, and related diseases.

F. Bone, Reproductive, and Urologic Drugs Advisory Committee (formerly Advisory Committee for Reproductive Health Drugs): Reviews and evaluates available data on the safety and effectiveness of marketed and investigational human drugs for use in the practice of osteoporosis and metabolic bone disease, obstetrics, gynecology, urology, and related specialties.

G. Cardiovascular and Renal Drugs Advisory Committee: Reviews and evaluates available data on the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cardiovascular and renal disorders.

H. Dermatologic and Ophthalmic Drugs Advisory Committee: Reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of dermatologic and ophthalmic disorders.

I. Drug Safety and Risk Management Advisory Committee: Reviews and evaluates information on risk management, risk communication, and quantitative evaluation of spontaneous reports for drugs for human use.

J. Endocrinologic and Metabolic Drugs Advisory Committee: Reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of endocrine and metabolic disorders.

K. Gastrointestinal Drugs Advisory Committee: Reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of gastrointestinal diseases.

L. Medical Imaging Drugs Advisory Committee: Reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in diagnostic and therapeutic procedures using radioactive pharmaceuticals and contrast media used in diagnostic radiology.

M. Nonprescription Drugs Advisory Committee: Reviews and evaluates available data concerning the safety and effectiveness of over-the-counter (nonprescription) human drug products for use in the treatment of a broad spectrum of human symptoms and diseases.

N. Oncologic Drugs Advisory Committee: Reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer.

O. Peripheral and Central Nervous System Drugs Advisory Committee: Reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of neurologic diseases.

P. Pharmacy Compounding Advisory Committee: Provides advice on scientific, technical, and medical issues concerning drug compounding.

Q. Psychopharmacologic Drugs Advisory Committee: Reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the practice of psychiatry and related fields.

R. Pulmonary-Allergy Drugs Advisory Committee: Reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of pulmonary disease and diseases with allergic and/or immunologic mechanisms.

Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests should send a letter stating that interest to the FDA contact (see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of this document (see DATES). Within the subsequent 30 days, FDA will send a letter to each organization that has expressed an interest, attaching a complete list of all such organizations and a list of all nominees along with their current resumes. The letter will also state that it is the responsibility of the interested organizations to confer with one another and to select a candidate, within 60 days after the receipt of the FDA letter, to serve as the nonvoting member to represent industry interests for the committee. The interested organizations are not bound by the list of nominees in selecting a candidate. However, if no individual is selected within 60 days, the Commissioner will select the nonvoting member to represent industry interests.

Individuals may self-nominate and/or an organization may nominate one or more individuals to serve as a nonvoting industry representative. Contact information, a current curriculum vitae, and the name of the committee of interest should be sent to the FDA Advisory Committee Membership Nomination Portal (see ADDRESSES) within 30 days of publication of this document (see DATES). FDA will forward all nominations to the organizations expressing interest in participating in the selection process for the committee. (Persons who nominate themselves as nonvoting industry representatives will not participate in the selection process).

FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.

This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

Section 905 of the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) mandates FDA to develop an enhanced ability to monitor the safety of drugs after these products reach the market. In response to this mandate, FDA launched its Sentinel Initiative, a long-term program designed to build and implement an electronic system for monitoring the safety of medical products in the post market setting. FDA has already created significant infrastructure on which to operate such a system: Through its Mini-Sentinel pilot, a distributed database with access to more than 150 million patient records has been created (the Sentinel Distributed Database). In order to optimally leverage these data, however, new analytic methodologies will be required. IMEDS-Methods is a program within the Reagan-Udall Foundation that supports FDA's scientific mission of serving public health needs by initiating and facilitating research into the methods of safety evaluation in large databases. IMEDS-Methods aims to improve the tools for conducting post-marketing safety surveillance using automated healthcare data and to foster their adoption.

IMEDS plans to conduct methods research in five core areas: (1) Addressing bias in estimates from observational studies; (2) better understanding uses and limitations of the data; (3) applying lessons learned from earlier IMEDS projects to FDA surveillance activities; (4) expanding the surveillance question to continuous risk/benefit assessment; and (5) continuing to support qualified investigators in industry, government, and academic settings by providing access to de-identified electronic healthcare data and computing resources through the IMEDS Research Laboratory.

Eligibility is limited to the Reagan-Udall Foundation. The Reagan-Udall Foundation has established the IMEDS-Methods program, which is uniquely positioned to develop the new methodologies required for FDA to conduct effective active post market safety surveillance of medical products using large electronic health care data. The IMEDS organization has developed a network of statisticians, epidemiologists, data scientists, and clinicians who have experience operating in both the IMEDS research laboratory and also familiarity with the Sentinel Distributed Database. In addition, through the Reagan-Udall Foundation public-private partnership, the IMEDS-Methods program has a unique ability to convene FDA, patients, academics, government, and industry so that the findings and tools developed through its research agenda will be promulgated and adopted.

FDA/CDER intends to fund up to $1,000,000 in fiscal year 2015 in support of this program project. It is anticipated that only one award will be made, not to exceed $1,000,000 (direct plus indirect) for total costs.

There is a one year period of performance beginning on June 15, 2015 or the date of award.

Only one electronic application will be accepted. To submit an electronic application in response to this FOA, the applicant should first review the full announcement located at http://www.grants.gov/. (FDA has verified the Web site addresses throughout this document, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.)

For the electronically submitted application, the following steps are required.

• Step 1: Obtain a Dun and Bradstreet (DUNS) Number

• Step 2: Register With System for Award Management (SAM)

• Step 3: Obtain Username & Password

• Step 4: Authorized Organization Representative (AOR) Authorization

• Step 5: Track AOR Status

• Step 6: Register With Electronic Research Administration (eRA) Commons

Steps 1 through 5, in detail, can be found at http://www07.grants.gov/applicants/organization_registration.jsp. Step 6, in detail, can be found at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp. After you have followed these steps, submit the electronic application to: http://www.grants.gov.

When submitting comments or requesting information, please include the OMB control number 0990-0382 and document identifier HHS-OS-30D for reference.

Abstract: The Office of Adolescent Health (OAH), U.S. Department of Health and Human Services (HHS) is requesting an extension without change of a currently approved information collection request by OMB. The purpose of the extension is to complete the ongoing follow-up data collection for the Evaluation of Adolescent Pregnancy Prevention Approaches (PPA), a multi-site random assignment evaluation of promising approaches to teen pregnancy prevention.

Need and Proposed Use of the Information: The PPA study is being conducted in seven program sites around the country. The proposed extension is necessary to complete ongoing follow-up data collection in five of the seven study sites. The resulting data will be used in a rigorous program impact analysis to assess the effectiveness of each program in reducing rates of teen pregnancy and associated sexual risk behaviors.

Likely Respondents: The 1484 youth participants who agreed to participate in the study upon sample enrollment in 5 impact study sites.

The total annual burden hours estimated for this ICR are summarized in the table below.

Background: In 2008, NIEHS/NTP, the U.S. Environmental Protection Agency's (EPA) National Center for Computational Toxicology (NCCT), and the National Human Genome Research Institute (NHGRI)/NIH Chemical Genomics Center (NCGC) (now located within the National Center for Advancing Translational Sciences (NCATS)) entered into a formal agreement to develop a vision and devise an implementation strategy to shift the assessment of chemical hazards from traditional, experimental animal, toxicology studies to target-specific, mechanism-based, biological observations largely obtained using in vitro assays. In mid-2010, the U.S. Food and Drug Administration (FDA) joined the collaboration that is known informally as Tox21.

Tox21 partner agencies collaborate to research, develop, validate, and translate innovative testing methods for characterization of toxicity pathways; identify compounds, assays, informatic analyses, and targeted testing needed to support the development of new methods; identify patterns of compound-induced biological response(s) in order to characterize toxicity pathways; facilitate cross-species and low-dose extrapolation; prioritize compounds for more extensive toxicological evaluation; and develop predictive models for biological response in humans. The primary activity of Tox21 Phase I was the development of a quantitative high throughput screening (qHTS) approach for toxicology. The goal of Phase II was the implementation of the qHTS approach in screening a 10,000 compound library through a variety of nuclear receptor agonist/antagonist and stress response pathway assays, utilizing primarily reporter gene platforms. In Phase III, the focus is on assaying chemicals in high-content screens and mid to high throughput transcriptomic screens. High throughput gene expression changes will be the primary metric that is employed in Phase III to measure biological effects from chemical exposures.

To conduct Tox21 Phase III, Tox21 partners initiated the “S1500 Genes High Throughput Transcriptomics” project to capture information from the whole transcriptome (i.e., the entirety of all expressed RNA molecules in a cell or biological sample). This project will use a targeted subset of genes in a HTS or semi-HTS platform to gain insight into how biological systems respond to chemical exposures. Neither the actual number of genes to be utilized, nor the specific transcriptomics platform(s) needed to carry out the project, have been finalized.

In an effort to select an appropriate subset of key representative or “sentinel” genes, the NTP previously requested input from the scientific community (78 FR 45542, July 29, 2013) on the “Nomination and Prioritization of Environmentally Responsive Genes for Use in Screening Large Numbers of Substances Using Toxicogenomic Technologies.” An interagency working group composed of members of the Tox21 partnership considered the input provided in response to the Federal Register notice as they developed a consensus strategy to select appropriate genes.

The working group's goal was to select the most relevant and biologically diverse set of sentinel genes to represent transcriptomic responses to injury. Criteria for the selection and evaluation of an appropriate gene set are: (1) Representative of highly diverse gene expression changes reported to date, (2) capable of predicting the gene expression changes observed across the transcriptome, and (3) coverage of all major biological pathways.

The current version of the human S1500 gene set can be found at http://ntp.niehs.nih.gov/go/S1500. This site will be updated as changes to the list are made. The consensus strategy for selection of an appropriate sentinel gene set can be accessed at the same site.

Comments on the human S1500 gene set should be submitted electronically in Microsoft Excel or Word format to [email protected].

Respondents to this request are asked to provide their name, affiliation, address, and contact information (including telephone and fax numbers, and email address). The deadline for receipt of comments is May 15, 2015.

Responses to this request are voluntary. This notice does not obligate the U.S. Government to award a contract or otherwise pay for the information provided in response to this request. The U.S. Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this request should ensure that its response is complete and sufficiently detailed. Respondents are advised that the U.S. Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. No proprietary, classified, confidential, or sensitive information should be included in your response.

Background Information on the NTP: The NTP is an interagency program established in 1978 (43 FR 53060) to strengthen the Department's activities in toxicology research and testing and to develop and validate new and better testing methods. Other activities of the program focus on strengthening the science base in toxicology and providing information about potentially toxic chemicals to health-regulatory and research agencies, scientific and medical communities, and the public. The NTP is located administratively at the NIEHS. Information about NTP and NIEHS is available at http://ntp.niehs.nih.gov and http://www.niehs.nih.gov, respectively.

This notice informs the public that HUD has submitted to OMB a request for approval of the information collection described in Section A.

The Federal Register notice that solicited public comment on the information collection for a period of 60 days was published on February 9, 2015 at 80 FR 7028.

Title of Information Collection: Community Development Block Grant (CDBG) Urban County Qualification/Requalification Processes.

OMB Approval Number: 2506-0170.

Type of Request: Revision of currently approved collection.

Form Numbers: N/A.

Description of the need for the information and proposed use: The Housing and Community Development Act of 1974, as amended, at sections 102(a)(6) and 102(e) requires that any county seeking qualification as an urban county notify each unit of general local government within the county that such unit may enter into a cooperation agreement to participate in the CDBG program as part of the county. Section 102(d) of the statute specifies that the period of qualification will be three years. Based on these statutory provisions, counties seeking qualification or requalification as urban counties under the CDBG program must provide information to HUD every three years identifying the units of general local governments (UGLGs) within the county participating as a part of the county for purposes of receiving CDBG funds. The population of UGLGs for each eligible urban county is used in HUD's allocation of CDBG funds for all entitlement and State CDBG grantees.

New York towns undertook a similar process every three years. However, after consultation with program counsel, it was determined that a requalification process for New York towns is unnecessary because the units of general local government in New York towns do not have the same statutory notice rights (under Section 102(e) of the Housing and Community Development Act of 1974) as units of general local government participating in an urban county. In addition, each New York town has automatic renewing agreements with the incorporated units of general local governments contained within their boundaries. Therefore, it is presumed that all incorporated units of general local government will continue to participate in the New York towns in which they are located unless Headquarters is notified to the contrary.

Respondents: Urban counties that are eligible as entitlement grantees of the CDBG program.

Estimation Number of Respondents: There are currently 185 qualified urban counties participating in the CDBG program that must requalify every three years.

Frequency of Response: On average, two new counties qualify each year. The burden on new counties is greater than for existing counties that requalify. The Department estimates new grantees use, on average, 100 hours to review instructions, contact communities in the county, prepare and review agreements, obtain legal opinions, have agreements executed at the local and county level, and prepare and transmit copies of required documents to HUD. The Department estimates that counties that are requalifying use, on average, 60 hours to complete these actions. The time savings on requalification is primarily a result of a grantee's ability to use agreements with no specified end date. Use of such “renewable” agreements enables the grantee to merely notify affected participating UGLGs in writing that their agreement will automatically be renewed unless the UGLG terminates the agreement in writing, rather than executing a new agreement every three years.

This total number of combined burden hours can be expected to increase annually by 200 hours, given the average of two new urban counties becoming eligible entitlement grantees each year.

This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:

(1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(2) The accuracy of the agency's estimate of the burden of the proposed collection of information;

(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and

(4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

HUD encourages interested parties to submit comment in response to these questions.

This notice informs the public that HUD has submitted to OMB a request for approval of the information collection described in Section A.

The Federal Register notice that solicited public comment on the information collection for a period of 60 days was published on February 9, 2015 at 80 FR 7027.

Title of Information Collection: Community Development Block Grant Entitlement Program.

OMB Approval Number: 2506-0077.

Type of Request: Revision of currently approved collection.

Form Numbers: N/A.

Description of the need for the information and proposed use: This request identifies the estimated reporting burden associated with information that CDBG entitlement grantees will report in IDIS for CDBG-assisted activities, recordkeeping requirements, and reporting requirements. Grantees are encouraged to update their accomplishments in IDIS on a quarterly basis. In addition, grantees are required to retain records necessary to document compliance with statutory and regulatory requirements, Executive Orders, applicable OMB Circulars, and determinations required to be made by grantees as a determination of eligibility. Grantees are required to prepare and submit their Consolidated Annual Performance and Evaluation Reports, which demonstrate the progress grantees make in carrying out CDBG-assisted activities listed in their consolidated plans. This report is due to HUD 90 days after the end of the grantee's program year. The information required for any particular activity is generally based on the eligibility of the activity and which of the three national objectives (benefit low- and moderate-income persons; eliminate/prevent slums or blight; or meet an urgent need) the grantee has determined that the activity will address.

Respondents: Grant recipients (metropolitan cities and urban counties) participating in the CDBG Entitlement Program.

Estimation Number of Respondents: 1,164.

Estimation Number of Responses: The proposed frequency of the response to the collection is on an annual basis.

Frequency of Response: Annually.

Total Estimated Burdens: The total estimated burden is 544,984.

This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:

(1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(2) The accuracy of the agency's estimate of the burden of the proposed collection of information;

(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and

(4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

HUD encourages interested parties to submit comment in response to these questions.

Why do we conduct a 5-year review?

Under the Act (16 U.S.C. 1531 et seq.), we maintain Lists of Endangered and Threatened Wildlife and Plants (which we collectively refer to as the List) in the Code of Federal Regulations (CFR) at 50 CFR 17.11 (for animals) and 17.12 (for plants). Section 4(c)(2)(A) of the Act requires us to review each listed species' status at least once every 5 years. Our regulations at 50 CFR 424.21 require that we publish a notice in the Federal Register announcing those species under active review. For additional information about 5-year reviews, refer to our factsheet at http://www.fws.gov/endangered/what-we-do/recovery-overview.html.

A 5-year review considers all new information available at the time of the review. For all five of these species, this will be the second 5-year review developed for each species. In conducting these reviews, we consider the best scientific and commercial data that have become available since the listing determination or most recent status review, such as:

(A) Species biology, including but not limited to population trends, distribution, abundance, demographics, and genetics;

(B) Habitat conditions, including but not limited to amount, distribution, and suitability;

(C) Conservation measures that have been implemented that benefit the species;

(D) Threat status and trends in relation to the five listing factors (as defined in section 4(a)(1) of the Act); and

(E) Other new information, data, or corrections, including but not limited to taxonomic or nomenclatural changes, identification of erroneous information contained in the List, and improved analytical methods.

Any new information will be considered during the 5-year review and will also be useful in evaluating the ongoing recovery programs for the species.

This notice announces our active review of the species listed in the table below.

The BAA is issued under the provisions of FAR Part 35. Proposals selected for eventual award are considered to be the result of full and open competition and in full compliance with the provision of Public Law 98-369, “The Competition in Contracting Act of 1984” and subsequent amendments. For additional information on the 3DEP program http://nationalmap.gov/3DEP/index.html.